COVID19 Infection
Conditions
Brief summary
The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
Interventions
DRUGCyclosporine
In the experimental group, cyclosporine will be started according to patient weight, and then increased depending on patient tolerance (monitoring renal function and blood pressure)
DRUGStandard treatment
Standard of care according to hospital protocol
Sponsors
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women and men over 18 years old 2. Clinical diagnosis of COVID19 infection (to be subsequently confirmed by PCR or specific IgM isotype Ac and with entry criteria according to the protocol of action (see Annex 2) 3. Acceptance and signing of the consent for the study after having received the appropriate information.
Exclusion criteria
1. Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components. 2. Contraindication for the use of any of the medications included (\*) * CsA: IR EST 4.5 (FG \<30 ml / min according to the Cockcroft-Gault formula) * Antimalarials (Chloroquine, hydroxychloroquine): Retinopathy, Myasthenia gravis. * Lopinavir / ritonavir: severe liver failure * Remdesivir, darunovir-ritonavir * Doxycycline, Azithromycin 3. Kidney failure (Stages 4 and 5: GFR \<30 ml / min according to the cockcroft-Gault formula). 4. Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B 5. Pregnancy or lactation 6. Age over 75 years 7. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed. 8. Refusal to participate 9. Patient with a poor state of health or nutrition who, in the opinion of the researcher, has sufficient criteria of severity to interfere with the development of the study or its conclusions 10. At the investigator's discretion, the patient's inability to understand or comply with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity Category | 12 days | efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | through study completion, an average of 6 weeks | efficacy of CsA in combination with standard treatment in reducing mortality |
| Number of Days in hospital | through study completion, an average of 6 weeks | efficacy of CsA in combination with standard treatment in reducing days in hospital |
| Number of days in ICU beds | through study completion, an average of 6 weeks | efficacy of CsA in combination with standard treatment in reducing days in ICU beds |
| Fio2 Needs | through study completion, an average of 6 weeks | efficacy of CsA in combination with standard treatment in reducing FiO2 needs. |
| Adverse events rate | through study completion, an average of 6 weeks | safety and tolerability of cyclosporine vs standard treatment administration |
| Change in CRP | every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies) | change from baseline in C reactive protein levels |
| Change specific antibodies | Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment) | Specific IgG and IgM determination |
| Change in LDH | every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment) | change from baseline in LDH levels |
| Change in CPK | every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies) | change from baseline in Creatin phosphokinase levels |
| Change in D Dimer | every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies) | change from baseline in D Dimer levels |
| Change in IL-6 | Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment) | change from baseline in IL-6 levels |
| Change in KL-6 | Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment) | change from baseline in KL-6 levels |
| Change in Viral Load | Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment) | COVID19 Viral load determination |
| Change in ferritin | every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies) | change from baseline in ferritin levels |
Countries
Spain
Outcome results
None listed